Floatz Rating
BB65/100
Confidence
Indicative
Sponsor
Miltenyi Biomedicine GmbH
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
65High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07569965CT.gov Frontline Risk-Adapted Optimization of Novel Targeted Immunotherapy Evaluation in High-Risk MCL | — | Not Yet Recruiting | — | — | — |
NCT07341191CT.gov Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy | — | Recruiting | — | — | — |
NCT07261163CT.gov Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma | — | Recruiting | — | — | — |
NCT07225439CT.gov Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL) | — | Not Yet Recruiting | — | — | — |
NCT07259070CT.gov Multicenter, Single-Arm Exploratory Phase I Clinical Study (Assessment of Safety and Efficacy) of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Relapsed/Refractory BAFF-R-Positive B-Cell Lymphoma | — | Recruiting | — | — | — |
NCT07024147CT.gov JWCAR239 in Patients With B Cell Non-Hodgkin Lymphoma | — | Not Yet Recruiting | — | — | — |
NCT06208735CT.gov CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies | — | Recruiting | — | — | — |
NCT06343376CT.gov Genetically Engineered Cells (EGFRt/19-28z/IL-12 CAR T Cells) for the Treatment of Relapsed or Refractory CD19+ Hematologic Malignancies | — | Terminated | — | — | — |
NCT07168486CT.gov CD19.20.22 CAR T-cells for Patients With Relapsed/Refractory B-Cell Lymphomas | — | Enrolling By Invitation | — | — | — |
NCT06191887CT.gov B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies | — | Recruiting | — | — | — |
Show 57 more trialsShow fewer
NCT06253663CT.gov Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia | — | Active Not Recruiting | — | — | — |
NCT06026319CT.gov CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma | — | Recruiting | — | — | — |
NCT05665062CT.gov Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies | — | Active Not Recruiting | — | — | — |
NCT05694364CT.gov Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies | — | Completed | — | — | — |
NCT05495464CT.gov A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma | — | Active Not Recruiting | — | — | — |
NCT05155215CT.gov Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Mantle Cell Lymphoma | — | Unknown | — | — | — |
NCT05020392CT.gov Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma | — | Unknown | — | — | — |
NCT04792489CT.gov DALY II USA/ MB-CART2019.1 for DLBCL | — | Recruiting | — | — | — |
NCT04880434CT.gov Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3) | — | Completed | — | — | — |
NCT04735471CT.gov A Phase 1 Study of ADI-001 in B Cell Malignancies | — | Terminated | — | — | — |
NCT04844086CT.gov RPM CD19-mbIL15-CAR-T Cells in Patient With Advanced Lymphoid Malignancies | — | Terminated | — | — | — |
NCT04767308CT.gov Safety and Efficacy of CT125A Cells for Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies | — | Unknown | — | — | — |
NCT04195633CT.gov Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies | — | Recruiting | — | — | — |
NCT04223765CT.gov Study of Kappa Chimeric Antigen Receptor (CAR) T Lymphocytes Co-Expressing the Kappa and CD28 CARs for Relapsed/Refractory Kappa+ Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. | — | Recruiting | — | — | — |
NCT04545762CT.gov Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma | — | Recruiting | — | — | — |
NCT03579888CT.gov CD19-Specific T Cells Post AlloSCT | — | Terminated | — | — | — |
NCT04323657CT.gov TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia | — | Completed | — | — | — |
NCT04049513CT.gov ENABLE-1 (Engaging Toll-like Receptor Signalling for B-cell Lymphoma Chimeric Antigen Receptor Therapy) | — | Active Not Recruiting | — | — | — |
NCT04007029CT.gov Modified Immune Cells (CD19/CD20 CAR-T Cells) in Treating Patients With Recurrent or Refractory B-Cell Lymphoma or Chronic Lymphocytic Leukemia | — | Active Not Recruiting | — | — | — |
NCT03622788CT.gov Cytokine-Treated Veto Cells in Treating Patients With Hematologic Malignancies Following Stem Cell Transplant | — | Active Not Recruiting | — | — | — |
NCT03674411CT.gov Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy | — | Active Not Recruiting | — | — | — |
NCT03676504CT.gov Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR | — | Recruiting | — | — | — |
NCT03314974CT.gov Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders | — | Recruiting | — | — | — |
NCT03277729CT.gov A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas | — | Active Not Recruiting | — | — | — |
NCT02722668CT.gov UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep | — | Completed | — | — | — |
NCT02661035CT.gov Allo HSCT Using RIC for Hematological Diseases | — | Completed | — | — | — |
NCT01962636CT.gov Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for Hematological Diseases | — | Terminated | — | — | — |
NCT02685670CT.gov Competitive Transfer of αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T Cells for B-cell Leukemia/Lymphoma | — | Unknown | — | — | — |
NCT02601313CT.gov Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2) | — | Completed | — | — | — |
NCT02153580CT.gov Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia | — | Active Not Recruiting | — | — | — |
NCT01163201CT.gov T-Regulatory Cell and CD3 Depleted Double Umbilical Cord Blood Transplantation in Hematologic Malignancies | — | Withdrawn | — | — | — |
NCT01527045CT.gov Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies | — | Completed | — | — | — |
NCT01597778CT.gov Double Cord Versus Haploidentical (BMT CTN 1101) | — | Completed | — | — | — |
NCT01578343CT.gov Vorinostat Plus FND in Relapsed or Refractory Mantle Cell Lymphoma | — | Terminated | — | — | — |
NCT01389427CT.gov Escalating Doses of Torisel in Combination With Three Chemotherapies Regimens: R-CHOP, R-FC or R-DHA for Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL). | — | Completed | — | — | — |
NCT01658319CT.gov Methoxyamine and Fludarabine Phosphate in Treating Patients With Relapsed or Refractory Hematologic Malignancies | — | Completed | — | — | — |
NCT01322776CT.gov Combination of Bortezomib, Fludarabine and Cyclophosphamide Treat Recurrent Mantle Cell Lymphoma | — | Unknown | — | — | — |
NCT01251575CT.gov Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant | — | Completed | — | — | — |
NCT01231412CT.gov Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant | — | Completed | — | — | — |
NCT01181271CT.gov Tandem Auto-Allo Transplant for Lymphoma | — | Completed | — | — | — |
NCT01088048CT.gov Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia | — | Completed | — | — | — |
NCT01044745CT.gov Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer | — | Terminated | — | — | — |
NCT00942409CT.gov Study of Repeat Intranodal Injections of Ad-ISF35 | — | Terminated | — | — | — |
NCT00924326CT.gov CAR T Cell Receptor Immunotherapy for Patients With B-cell Lymphoma | — | Completed | — | — | — |
NCT00789776CT.gov Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation, and Donor Bone Marrow Transplant Followed by Donor Natural Killer Cell Therapy, Mycophenolate Mofetil, and Tacrolimus in Treating Patients With Hematologic Cancer | — | Completed | — | — | — |
NCT00594308CT.gov In-Vivo Activated T-Cell Depletion to Prevent GVHD | — | Terminated | — | — | — |
NCT00621452CT.gov Genetically Engineered Lymphocytes, Cyclophosphamide, and Aldesleukin in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or Indolent B-Cell Non-Hodgkin Lymphoma | — | Completed | — | — | — |
NCT00536601CT.gov High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors | — | Completed | — | — | — |
NCT00719888CT.gov Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease | — | Completed | — | — | — |
NCT00118352CT.gov Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer | — | Completed | — | — | — |
NCT00119730CT.gov Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma | — | Completed | — | — | — |
NCT00105001CT.gov Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer | — | Completed | — | — | — |
NCT01456351CT.gov Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab | — | Completed | — | — | — |
NCT00058227CT.gov Alvocidib, Fludarabine Phosphate, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma | — | Completed | — | — | — |
NCT00183989CT.gov Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma | — | Terminated | — | — | — |
NCT00006251CT.gov Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine, Mycophenolate Mofetil, Donor Lymphocyte Infusion in Treating Patients With Hematopoietic Cancer | — | Completed | — | — | — |
NCT04162756CT.gov Study of Brexucabtagene Autoleucel (KTE-X19) for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies | — | Approved For Marketing | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Mantle Cell Lymphoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Fludarabine (this asset) | Miltenyi Biomedicine GmbH | P3 | BB · 65 |
| Etoposide | Ruijin Hospital | P4 | BBB |
| Cis-Diamminedichloroplatinum Ii | National Cancer Institute (NCI) | P4 | BBB |
| Busulfanum | City of Hope Medical Center | P2 | BBB |
| Vincristine Sulfate | M.D. Anderson Cancer Center | P2 | BBB |
| Cyclosporin A | Fred Hutchinson Cancer Center | P3 | BBB |
| Irinotecan | University of Michigan Rogel Cancer Center | P2 | BBB |
| Cediranib | City of Hope Medical Center | P2 | BB |
| Cyclophosphamide | Miltenyi Biomedicine GmbH | P4 | BB |
+42 more in the Mantle Cell Lymphoma cohort
Other indications for Fludarabine
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Adult T-Cell Leukemia/Lymphoma | — | P2 | BBB · 76 |
| Acute Myeloid Leukemia With Abnormal Bone Marrow Eosinophils Inv(16)(P13q22) Or T(16;16)(P13;Q22) | — | P2 | BBB · 76 |
| Fanconi Anemia | — | P2/3 | BBB · 76 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Fludarabine in Mantle Cell Lymphoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 9, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/fludarabine-mantle-cell-lymphoma-8047
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